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European Pharmaceutical Contractor

Going Local

The appeal of sourcing comparator locally is obvious, given the ever-present demands of tight timelines and budget constraints in the clinical trial arena. Two out of three managers polled during a recent webinar indicated that they have either turned to local markets for comparator sourcing, or are considering this option for a future study. Managers who have already taken the plunge into local sourcing recite a host of compelling reasons for doing so – among them are product availability, timing, regulatory and clinical requirements, plus obstacles to importing comparators in some of the most desirable countries for conducting clinical trials.

While local sourcing of comparators can be an effective option, it is important to keep in mind that it is not a solution for every challenge. The decision to source locally requires weighing a great many factors that include the preferred comparator, the countries participating in the study and the demands of the protocol.

Other aspects to consider are the resources required to manage a trial that includes the local sourcing of comparator. Executing any local sourcing strategy demands a high level of management throughout the study.

Options Defined


Any sourcing discussion must begin with the types of options available. There are three types – central, local and hybrid – and each plays an equally important role in the supply chain.

Central sourcing is the sourcing of a commercial drug in one country for use in all countries participating in a clinical trial. For example, a drug manufactured in the UK is shipped to a labelling facility, where a global label is applied and the drug is then transported to countries taking part in the study.

Local sourcing is the purchase of a commercial drug in a single country for use in that country; for instance, sourcing a chemotherapeutic agent in Russia for use in a trial taking place at Russian investigator sites. Depending upon the circumstances, supply chain professionals can implement a number of local sourcing strategies:

Local Sourcing with Export for Re-Import

This involves the purchase of a locally registered comparator, and the export of that drug to a regional hub in another country that has a Good Manufacturing Practice (GMP) labelling facility. Postlabelling, the drug is re-imported to the original country and shipped to local study sites. This is an option if the provider lacks an in-country GMP facility for packaging and labelling, if the sponsor prefers not to use a local facility for that purpose, or if the drug is purchased in a market without a depot or distribution hub for direct-to-site shipment.

Product without Registration

In this case, comparator is sourced in a country where it is registered and transported to another country where it is not, but with which it shares a common language. An example would be comparator purchased in Russia and shipped for use in neighbouring Belarus.

Local Make-Up
This strategy involves centrally sourcing local make-up product that is designated for use in several countries directly from a manufacturer. The drug is usually made only once or twice per year with a long lead time and delivered directly to a regional depot.

Combined Make-Up

The production of international packs is an originator option when the market need in individual countries is too small. Labelled in English, international packs are generic in nature, produced without marketing authorisation numbers and approved for use in multiple countries. An example is the sourcing of an international pack approved for use in three Asian countries from a Swiss manufacturer.

Hybrid sourcing is a combination of local and central sourcing. An example is the sourcing of a drug in Germany, where it is packaged, labelled and shipped to all EU countries participating in a clinical trial. When a study is taking place in both major and emerging markets, it might be necessary to source comparator locally for emerging markets. Some of these markets, including Russia and China, require local sourcing of comparator drugs.

Sourcing decisions require careful consideration of key factors, among them the desired comparator, country selection, regulatory landscape, import/export complexity, protocol requirements and, of course, cost considerations.

Pros and Cons


In deciding whether to source locally, it is important to consider both advantages and disadvantages. Always review available options with all key stakeholders in order to reach informed decisions.

The benefits of local sourcing include:
  • Minimal unnecessary labelling, with an auxiliary label often the only addition needed for an investigational medicinal product (IMP) or non-IMP (nIMP) that stays within a country
  • A simpler clinical trial application (CTA), because the reference product is sourced locally, open-label and not being manipulated
  • Minimal paperwork, with potential freight and tax savings, since no importation is required
  • Speed of supply, because locally sourced products can often be available in a fortnight or less
  • The advantage of having the product/ patient insert printed in the local language
Among the disadvantages of local sourcing are:
  • Intense lifecycle management throughout a study, thanks to depot complexity, packaging and labelling activities, completion and review of batch records, and the need to manage distribution networks. Operations and reconciliation work at the end of a study is also greater
  • Demanding expiry management/lot transition requirements, because the IMPs being evaluated often have short expiry dates
  • A higher scrap risk, since locally sourced comparator cannot be reallocated for use in another country
  • A heavier administrative burden for the procurement, logistics and finance staff
  • The difficulty of managing a foreign product in a foreign language from an operations standpoint
When to Consider Local Sourcing

To succeed with local sourcing, strike a balance between the costs of the product and a host of other factors, including operational expenses and capabilities, the local needs of depots and the resources required to manage the trial. The decision to source locally should be based upon careful consideration of available resources – both internal and through a partner – subject matter expertise, the existing network, and protocol and access complexity.

IMPs can be a good option for local sourcing when they are supplied open-label, without requiring blinding, repackaging or manipulation. nIMPs – including standard of care and rescue medications, background therapy, co-medications and chemotherapy – can also be candidates for local sourcing.

When local sourcing is a possibility, bear the following in mind:
  • There may be substantial unit cost differences locally versus centrally for comparator
  • It may be impossible to shop around for a better price when sourcing comparator locally. In countries such as Russia, for example, prices are set and there is little room for negotiation; market conditions may also change rapidly
  • However, when sourcing centrally in the EU for a trial taking place in EU countries, shopping around for a good price is recommended
  • When the comparator is expensive, investigate price differences and taxes among regions and countries to grasp the bigger picture
  • Consider both product and operational costs associated with comparator. It can be difficult to quantify the added cost and labour that a locally sourced drug will add to the resource structure, but doing so is necessary
  • The regulatory landscape and import/ export complexity often drive sourcing decisions. If comparator cannot be imported due to regulatory constraints, or necessary documentation is unavailable, local sourcing may be the only solution
Product Availability

The ability to obtain sufficient product and the required documentation are often make-or-break issues for a local sourcing strategy. Address these problems before making sourcing decisions to avoid difficulties later.

Small Countries

There may be limited manufacturing runs of the desired comparator, and thus insufficient products on the market to meet clinical trial requirements. Due to limited production runs, resupplies could bear the same expiry date. Possible solutions include considering madeto- order from the manufacturer, switching to regional or central sourcing if permitted or – if local sourcing is mandatory – strategically planning trial resupply in conjunction with the manufacturer’s resupply schedule.

Hospital Line Products

The manufacturer may deliver directly to hospital pharmacies, making the product unavailable on the open/wholesaler market due to a restricted supply chain. The only option may be convincing the manufacturer to make an exception and sell products directly for trial use.

Product Documentation

Documentation differs by country and region, and obtaining it can pose substantial challenges. Meanwhile, regulatory affairs may require certain protocols for the preparation of CTAs and for import/ export purposes. Before making sourcing decisions, work with internal peers to identify mandatory paperwork and with the comparator supplier to learn if the necessary documentation is available.

Quality and Compliance


Maintaining quality standards, following local regulations and laws, and meeting tax and currency requirements can be complicated when implementing a local sourcing strategy.

GMP/GDP
As with all sourcing approaches, local sourcing decisions require compliance with GMP and Good Distribution Practice (GDP) standards. This can be challenging in some markets due to uneven interpretations of these standards, or the use of other ones. Keep in mind that GDP is not used globally. EU GDP must be followed only in Europe, for example. Other regions and countries can have different standards.

Regulations
Changing regulations can also pose compliance challenges. One far-reaching new regulation is the Drug Supply Chain Security Act, which established a nationwide drug track-and-trace system to prevent counterfeit or illegitimate medications from entering the US. Such regulations underscore the importance of qualifying wholesalers and distributors before partnering with them, to ensure sustainability of supply throughout studies (1,2).

Taxes, Local Laws and Currency

Complying with taxes and other local laws, including those regarding currency use, is not an option. Local, import and VAT can be complicated when sourcing locally. VAT, which must be paid on locally sourced comparator that does not leave the country, can be particularly tricky, as VAT rates and rules differ by country. In some countries, local registration is required for VAT compliance and reimbursement; in others, a legal entity is needed for a VAT transaction.

Finally, keep in mind that some Asian, Latin American and European countries impose restrictions on the use of foreign or local currency.

Eight Best Practices

1. Begin early: the earlier you learn that comparator sourcing is required, the more time is available to make informed sourcing decisions
2. Purchase samples to test, translate and understand: analyse these products. Translate labels and instructions to understand the drug. Gather pertinent information for documentation
3. Strategise internally and externally: work with all stakeholders to choose the best comparator and sourcing solution for the study design
4. Understand regulatory, quality, operational and clinical requirements: know what is required and the associated challenges before executing the study with the comparator in question
5. Consider all potential sourcing solutions and the impact of each on the commercialisation strategy, the global study and all stakeholders: engaging a supplier offering the full breadth of comparator sourcing options – central, local and hybrid – leads to a tailored and disinterested sourcing solution
6. If possible, select a partner with end-toend solutions to support you: integrating one partner who is able to provide a broad range of services (sourcing capabilities, importer of record, local depots, local labelling and so forth) will save both time and money, while also removing the need to coordinate with multiple suppliers
7. Have a fully compliant network internally and externally to strengthen your own position: remember, you cannot be compliant if your suppliers are not
8. Always put patient safety and product quality first: if you were a patient, would you want to receive that drug?

References
1. FDA, Drug Supply Chain Security Act. Visit: www.fda.gov/drugs/drugsafety/ drugintegrityandsupplychainsecurity/ drugsupplychainsecurityact
2. FDA, Are you ready for the Drug Supply Chain Security Act? Visit: www.fda.gov/drugs/ drugsafety/drugintegrityandsupplychainsecurity drugsupplychainsecurityact/ucm427033.htm

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Guillaume Brulebois joined Fisher Clinical Services in 2013 as Supply Chain Manager in the Supply Optimisation Group. He currently holds the position of Comparator Program Manager, based in Basel, Switzerland, leading the efforts in streamlining processes and designing solutions to support local sourcing approaches for sponsors. Prior to joining the organisation, Guillaume spent 10 years in project management, business development and marketing groups for preclinical and clinical CROs.
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Guillaume Brulebois
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